Ambroxol Hydrochloride Related Compounds & Impurities

Ambroxol Hydrochloride is the active metabolite of bromhexine and a widely used mucolytic agent that promotes surfactant secretion and enhances mucociliary clearance in respiratory tract disorders.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Ambroxol Hydrochloride reference standards, pharmacopeial and non-pharmacopeial Ambroxol Hydrochloride impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Ambroxol Hydrochloride-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Ambroxol Hydrochloride
Ambroxils
Ambroxol Theophillinate
Telmisartan Bromo Methyl Ester
Ambroxol EP Impurity B Hydrochloride
Ambroxol Hydrochloride EP Impurity B
Ambroxol EP Impurity B Oxalate
Ambroxol Hydrochloride EP Impurity E
Ambroxol Cycloimine Impurity Hydrochloride
Ambroxol EP Impurity C Hydrochloride
Ambroxol Hydrochloride EP Impurity D Hydrochloride
Ambroxol Hydrochloride EP Impurity D
Cis-4-Aminocyclohexanol Hydrochloride
Trans-4-Aminocyclohexanol Hydrochloride
Ambroxol Impurity 4
Ambroxol Didesbromo Impurity
(1s,4s)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride
(1s,4s)-4-((2-amino-4-bromobenzyl)amino)cyclohexanol dihydrochloride
Ambroxol Hydrochloride EP Impurity C
N-Nitroso Ambroxol
N-(2,4-dibromo-6-{[(4-hydroxycyclohexyl)amino]methyl}phenyl)-2-hydroxyacetamide
N-(2,4-dibromo-6-{[(4-hydroxycyclohexyl)amino]methyl}phenyl)-2-hydroxypropanamide
Ambroxol Impurity 11
Ambroxol Cycloimine Impurity
Ambroxol Impurity 10 Hydrochloride
Ambroxol Impurity 3
N-Nitroso Ambroxol Impurity 1
Ambroxol Impurity 2
N-Nitroso Ambroxol Impurity 2
N-Nitroso Ambroxol Impurity 3
N-Nitroso Ambroxol Impurity 3
N-Nitroso Ambroxol Impurity 5
Ambroxol Impurity 6
Ambroxol Impurity 7
Ambroxol Impurity 8
Ambroxol Impurity 9

Isotope Labelled Compounds

Ambroxol -D5
Ambroxol D5 Hydrochloride